HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease for which there is not yet a cure. Antiretroviral therapy (ART) has proven an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival. Previous studies indicate that episodic use of ART is associated with increased risk of cardiovascular disease (CVD). This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

The plasma specimens will be collected using EDTA plasma tubes. For each specimen, four transport tubes (Sarstedt 2.0 mL Micro Tube), each containing 1 mL of plasma, will be prepared and labeled with preprinted bar coded labels. The preprinted bar coded labels specify the patient identification code (PID), visit and specimen type, and the protocol and vial ID. Specimens will be frozen at negative 70 degrees Celcius and shipped on dry ice to a central repository, Advanced Biomedical Laboratories, Cinnaminson, New Jersey, where they will be scanned and put into storage. Paperwork documenting the specimens will be processed by the SDMC, and electronic files will be sent to the central repository.

Participants from the SMART study who were randomly assigned to episodic or continuous ART and who have no history of CVD

Drug: Antiretroviral Therapy (ART)

Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.

Other Name: Anti-HIV therapy

2

Participants from the SMART study who were randomly assigned to episodic or continuous ART and who experienced a major CVD event during the study, analyzed along with 2 matched controls

Drug: Antiretroviral Therapy (ART)

Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.

Other Name: Anti-HIV therapy

3

Participants from the SMART study who have no previous use of ART or have taken ART but not done so within 6 months prior to study entry; allows for a comparison of immediate ART versus deferred ART

Drug: Antiretroviral Therapy (ART)

Either episodic ART or continuous ART. All groups will have plasma specimens taken to compare changes in lipoprotein particle sizes and numbers and changes in inflammatory and coagulation markers.

Other Name: Anti-HIV therapy

Detailed Description:

HIV is a virus that can lead to AIDS, a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Using ART treatments, people with HIV have been able to delay HIV replication and immune system deterioration and to improve quality of life. Data from the Strategies for Management of Antiretroviral Therapy (SMART) study indicate that episodic use of ART is associated with a higher risk of CVD than is continuous use of ART. The reasons behind this increased risk of CVD in the presence of HIV are not well understood. This study will determine mechanisms underlying the increased CVD risk among people infected with HIV and, specifically, in those who receive episodic ART.

This ancillary study to SMART will use relevant data and specimens from three subsamples of SMART participants and key subgroups. The three subsamples include participants randomly assigned to episodic or continuous ART, participants who had no previous use of ART prior to study entry or had ceased ART within 6 months prior to study entry, and participants who had experienced a CVD event with two matched controls for each case. The subgroups will include episodic and continuous ART participants who were taking either a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) at study entry.

This current study will use previously collected SMART data. Researchers will use data on CD4+ count and HIV-RNA levels from a prebaseline study visit and follow-up study visits that occurred at Months 1 and 2, then every 2 months for Year 1, and every 4 months thereafter during the SMART study. In addition, this study will use baseline and yearly data provided by SMART participants on CVD risk factors and treatment, including use of drug treatments for high blood pressure, diabetes history, cholesterol levels, smoking history, white blood cell count, and height and weight measurements. Last, using plasma specimens that were collected at baseline, the Month 1 follow-up, and the final follow-up, researchers will compare changes in lipoprotein particle size and numbers, as measured by nuclear magnetic resonance (NMR) spectroscopy, and changes in inflammatory and coagulation markers.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

This study will utilize patient data and specimens already collected from the previous parent study, SMART.

Criteria

Inclusion Criteria:

Participant in the SMART study

CD4+ lymphocyte count greater than 350 cells/mm3

Exclusion Criteria:

Presence of life-threatening diseases

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577681

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute